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Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
comfilcon A toric lens
samfilcon A toric lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has had a self-reported oculo-visual examination in the last two years.
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
  • Is willing to wear contact lens in both eyes for the duration of the study;
  • Has a minimum astigmatism of - 0.75, determined by refraction;
  • Can be fit with the two study contact lens types in the powers available;
  • Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
  • Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
  • Has clear corneas and no active* ocular disease

Exclusion Criteria:

  • Is participating in any concurrent clinical trial;
  • Has any known active* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study measure;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
  • Has known sensitivity to fluorescein dye or products to be used in the study;
  • Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
  • Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  • Is aphakic;
  • Has undergone refractive error surgery.
  • Has participated in the PIANO (i.e. EX-MKTG-83) Study.

Sites / Locations

  • University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

comfilcon A toric lens

samfilcon A toric lens

Arm Description

Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.

Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.

Outcomes

Primary Outcome Measures

Comfort at Insertion
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Comfort
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Lens Preference Based on Overall Comfort
Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Lens Preference Based on Overall Dryness
Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Dryness
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Dryness
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

Secondary Outcome Measures

Ease of Insertion
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Ease of Insertion
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Ease of Insertion
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Ease of Removal
Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Ease of Removal
Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)

Full Information

First Posted
May 1, 2018
Last Updated
December 17, 2019
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03519932
Brief Title
Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses
Official Title
A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comfilcon A toric lens
Arm Type
Experimental
Arm Description
Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.
Arm Title
samfilcon A toric lens
Arm Type
Active Comparator
Arm Description
Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.
Intervention Type
Device
Intervention Name(s)
comfilcon A toric lens
Other Intervention Name(s)
Biofinity toric, test lens
Intervention Description
Contact lens
Intervention Type
Device
Intervention Name(s)
samfilcon A toric lens
Other Intervention Name(s)
Ultra for Astigmatism, control lens
Intervention Description
Contact lens
Primary Outcome Measure Information:
Title
Comfort at Insertion
Description
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Time Frame
Dispense
Title
Comfort
Description
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Time Frame
2 weeks
Title
Comfort
Description
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Time Frame
1-month
Title
Lens Preference Based on Overall Comfort
Description
Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Time Frame
1 month
Title
Lens Preference Based on Overall Dryness
Description
Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Time Frame
1 month
Title
Dryness
Description
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Time Frame
2 weeks
Title
Dryness
Description
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Time Frame
1-month
Secondary Outcome Measure Information:
Title
Ease of Insertion
Description
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame
Dispense
Title
Ease of Insertion
Description
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame
2-weeks
Title
Ease of Insertion
Description
Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame
1-month
Title
Ease of Removal
Description
Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame
2-weeks
Title
Ease of Removal
Description
Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Has had a self-reported oculo-visual examination in the last two years. Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day. Is willing to wear contact lens in both eyes for the duration of the study; Has a minimum astigmatism of - 0.75, determined by refraction; Can be fit with the two study contact lens types in the powers available; Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction; Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses. Has clear corneas and no active* ocular disease Exclusion Criteria: Is participating in any concurrent clinical trial; Has any known active* ocular disease and/or infection; Has a systemic condition that in the opinion of the investigator may affect a study measure; Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure; Has known sensitivity to fluorescein dye or products to be used in the study; Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses; Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); Is aphakic; Has undergone refractive error surgery. Has participated in the PIANO (i.e. EX-MKTG-83) Study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCOptom
Organizational Affiliation
Director, Centre for Ocular Research & Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

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